FDA

FDA to make recall data public beginning this year

Friday, February 21, 2014 by: J. D. Heyes
Tags: FDA, recall data, public information

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(NaturalNews) 2014 will be the year that the Food and Drug Administration begins making product recall data available to the public, in a further bid by the Obama administration to increase government transparency.

According to the Regulatory Affairs Professionals Society (RAPS), whose membership focus on the regulation of healthcare and related products, the FDA's project amounts to an "unprecedented" change in the agency's policies.

"Data transparency has been all the rage in the life science industry as of late, with industry groups and companies pledging to release their clinical trials data to researchers and the public," says an analysis of the project by RAPS. "But at the institutional level, transparency doesn't always mean access. Instead, sometimes the best transparency refers to ease of access.

"And now, thanks to a 2012 White House digital strategy initiative," the organization continued, "the U.S. Food and Drug Administration (FDA) is gearing up to grant the public unprecedented ease of access to some of its most sought-after information."

Part of a new era of transparency?

In May 2012, the Obama White House instructed the FDA and other federal agencies to begin immediate implementation of a new "digital strategy" designed to make governmental information more readily and easily accessible to the general public.

"Today's amazing mix of cloud computing, ever-smarter mobile devices, and collaboration tools is changing the consumer landscape and bleeding into government as both an opportunity and a challenge," said a 2012 report accompanying the White House memo ordering the initiative.

"To build for the future, the Federal Government needs a Digital Strategy that embraces the opportunity to innovate more with less, and enables entrepreneurs to better leverage government data to improve the quality of services to the American people," the memo said.

The crux of the report concentrated on what are known as APIs -- application programming interfaces -- which are standardized data formats specifying how various elements of software talk to each other.

Having open APIs would, hypothetically, give people access to raw data that the agency puts out through various databases that it operates. These would include adverse event reports, approvals, recall notices and the like; they would then be repurposed, potentially making them easier to use and/or more readable and useful.

Since the agency was given the White House directive in 2012, the FDA has not been very public regarding its open data efforts, said RAPS:

The Department of Health and Human Services (DHHS), FDA's parent organization, has been primarily focused on open data projects involving the rollout of the Affordable Care Act, and its Digital Strategy webpage seemingly contains just one FDA-related project: the November 2013 launch of FDA's new mobile-friendly website.

Uh, the website's down

That said, the FDA's limited actions regarding the federal Digital Strategy initiative seem poised to change in a big way. In January, the agency quietly announced the launch of a new webpage and initiative called "openFDA" (which was located at open.FDA.gov but could not be reached by Natural News when we attempted to do so for this story).

Advertised as an "exciting new initiative" that is to be operated by the FDA's Office of Informatics and Technology Innovation, "openFDA will offer easy access to FDA public data and highlight projects using these data in both the public and private sector to further regulatory or scientific missions, educate the public, and save lives."

The agency said that its new website would soon provide "API and raw download access to a number of high-value structured datasets," including adverse events, recalls and documentation such as structured product labeling (SPL) information.

But, as evidenced by our inability to pull up the site, as of this writing, the project is still very much in its infancy. And who knows -- perhaps the same company that built the glitch-prone federal online Obamacare exchange is in charge of building open.FDA.gov.

RAPS said the FDA initially announced that access to its site would not come until summer 2014 at the earliest, but given the Obamacare site's lingering problems, that date could change -- a lot.

Sources:

http://www.theverge.com

http://www.raps.org

http://www.hhs.gov

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